Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30
FDA 510(k) K081938 · Genzyme Diagnostics P.E.I., Inc.
510(k) numberK081938
Submission
- Device name
- Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30
- Applicant
- Genzyme Diagnostics P.E.I., Inc.
Charlottetown, Prin Ed Island, CA - Received
- July 8, 2008
- Decision date
- May 1, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDP – Colorimetry, Acetaminophen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3030
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LDP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261364 | Atellica CH Acetaminophen 2 (ACTM)LDP · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/24/2026SE |
| K202644 | AcetaminophenLDP · Traditional | Sekisui Diagnostics P.E.I., Inc. | 02/18/2022SE |
| K180835 | SEKURE Acetaminophen L3K AssayLDP · Traditional | Sekisui Diagnostics P.E.I., Inc. | 02/08/2019SE |
| K110726 | Roche Acetaminophen AssayLDP · Traditional | Roche Diagnostics | 12/23/2011SE |
| K100200 | Advia Chemistry Acetaminophen Reagent, Model Ref 07989138LDP · Traditional | Siemens Healthcare Diagnostics | 08/02/2010SE |
| K061655 | Dimension Vista Flex Reagent CartridgesLDP · Special | Dade Behring, Inc. | 07/10/2006SE |
| K043242 | Triage Tox Drug ScreenLDP · Traditional | Biosite Incorporated | 02/28/2005SE |
| K042330 | Acetaminophen-Sl AssayLDP · Traditional | Diagnostic Chemicals , Ltd. | 01/07/2005SE |
| K020792 | Acetaminophen Assay for the Advia Integrated Modular SystemLDP · Traditional | Bayer Diagnostics Corp. | 07/11/2002SE |
| K013757 | Roche AcetaminophenLDP · Traditional | Roche Diagnostics Corp. | 01/08/2002SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K082210 | Total Bilirubin L3K, Model 295-10 and 295-30CIG · Traditional | 12/16/2008SE |
Questions and answers
When was Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 cleared by the FDA?
Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 (K081938) received a 510(k) decision of Substantially Equivalent on May 1, 2009, 297 days after the submission was received.
What is the product code of K081938?
The FDA product code is LDP – Colorimetry, Acetaminophen, a Class II (moderate risk) device regulated under 21 CFR 862.3030.